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U.S. Department of Health and Human Services

Class 2 Device Recall Sheridan SHERISLIP and SOFTTIP Intubating Stylets

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 Class 2 Device Recall Sheridan SHERISLIP and SOFTTIP Intubating Styletssee related information
Date Initiated by FirmMay 11, 2017
Create DateJune 14, 2017
Recall Status1 Open3, Classified
Recall NumberZ-2587-2017
Recall Event ID 77330
Product Classification Stylet, tracheal tube - Product Code BSR
ProductSheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired shape during intubation.
Code Information Product Code 5-15103 - Lot Number 73J1600218, 73K1600376, 73K1600587, 73L1600158, 73M1600275, 73A1700733;
FEI Number 3005747797
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information ContactElizabeth Norwood
919-544-8000
Manufacturer Reason
for Recall		Product size listed on the labeling is incorrect.
FDA Determined
Cause 2		Labeling mix-ups
ActionRecall letters were sent to consignees on 5/11/2017 asking them to check inventory and immediately discontinue use of the product. The letter included a reply form to be returned. A separate letter was sent to distributors requesting that they conduct a sub-recall.
Quantity in Commerce21,690 eaches
DistributionWorldwide Distribution - US Nationwide in the states of CT, FL, ID, IN, KY, MA, MI, MN, MO, NE, NJ, NY, NC, OH, PA, RI, SD, TX, UT, WA and countries of Canada, Czech Republic, Denmark, Germany, Israel, & Portugal
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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